Unigene Laboratories has entered into an exclusive distribution agreement with Tzamal Bio Pharma to distribute its Fortical nasal spray in Israel for the treatment of osteoporosis.
According to the release, Tzamal will pay Unigene a fixed price per each unit of product it receives and has guaranteed minimum sales levels for the first three years following the product launch. Tzamal is also responsible for registering the product with the Israeli ministry of health, a process that normally requires 6-12 months, and they will reference Unigene's 2005 US approval to facilitate the regulatory review process.
"We are very happy to be the exclusive distributor of Fortical in Israel," Eddy Steinberg, GM of Tzamal Bio Pharma said adding, "We believe that the product will be well received as a safe alternative to the currently marketed osteoporosis therapies."
"This is a part of our broader strategy to introduce Fortical into additional territories and we feel that Tzamal is well positioned to maximize the product's market penetration in Israel," said Dr. Ronald S. Levy, Unigene's executive VP. "Once the product is approved, we will be supplying them with the identical units that we currently market in the US," he added.
Unigene is targeting its initial efforts on developing calcitonin and PTH-based therapies. Fortical, Unigene's nasal calcitonin product for the treatment of postmenopausal osteoporosis received FDA approval and was launched in August 2005. Unigene has licensed the US rights for Fortical to Upsher-Smith Laboratories, worldwide rights for its oral PTH technology to GlaxoSmithKline and worldwide rights for its calcitonin manufacturing technology to Novartis.